![]() ![]() ![]() – Device Master Records (DMR) content, development, and management – Design History Files (DHF) content, development, and management. ![]() – Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents. – Brief introduction to Lean Documents and Lean Configuration. RECORDED: Access recorded version only for one participant unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)ĭesign History File (DHF), Device Master Record (DMR), Device History Record (DHR) Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs – which is often redundant, repetitive, and chained together in a cumbersome way?ĭo you find that your design and manufacturing resources are spending way too much time on documentation and not enough on engineering and design? This webinar presents a fresh new approach based upon solid principles and proven practices as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.
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